Effects of Dietary Ingredients on Vascular Function

Vascular Diseases Clinical Trial

Official title:

Investigating the Effects of Dietary Ingredients on Vascular Function During Acute Glucose Load

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158481
• Other study ID #: FDS-BNH-0751
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: June 23, 2015
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The main aim of the study is to investigate the effects of dietary ingredients (polyphenols and carotenoids) on vascular function during acute glucose load. Each subject will receive 4 weeks of intervention with test product or placebo product after a dietary restriction run-in period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT) immediately after the run-in phase and at the end of the intervention phase. During the OGTT, blood samples will be taken at regular intervals.

The study will be conducted in subjects with impaired glucose tolerance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males or females confirmed with IGT;

• Age = 35 and = 65 year at screening;

• Body Mass Index (BMI) > 25 and <40 kg/m2;

• Reported intense sporting activities = 10h/w;

• Reported alcohol consumption = 14 units/week (female volunteers) or = 21 units/week (male volunteers)

• Currently not smoking and being a non-smoker for at least six months

Exclusion Criteria:

• Any medical condition or use of over-the-counter and prescribed medication which might affect study measurement (judged by the study physician);

• No reported participation in another nutritional or biomedical trial 3 months before screening;

• Reported weight loss or gain of 10% or more during a period of 6 months prior to screening;

• Anti-hyperglycemic drug or other medication which interferes with study measurements;

• No blood donation 1 month prior to screening;

• Reported allergy or intolerance to test products or other food products provided during the study;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance
• Vascular Diseases

Intervention

Dietary Supplement:
• A capsule containing both polyphenols and carotenoids

• Placebo intervention
Placebo intervention

Locations

Country	Name	City	State
United Kingdom	Aspect Clinical	Ledbury

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Aspect Clinical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-6 (IL-6) levels.		At baseline (after 2 weeks run-in period) and after 4 weeks intervention	No
Secondary	Pro-inflammatory and oxidative stress biomarkers	Luminex HS cytokine, CVD, ADK and MMP panel; Endothelial derived factors; Systemic inflammatory cytokines: hsTNFa; Systemic inflammatory cytokines: hsCRP; Endothelial cell function markers; Oxidative stress parameters	At baseline (after 2 weeks run-in period) and after 4 weeks intervention	No
Secondary	Cell stress-defence responses	Direct & indirect markers of cell defence activation; Inflammatory and oxidative stress markers; Established and exploratory cardiovascular health markers	At baseline (after 2 weeks run-in period) and after 4 weeks intervention	No
Secondary	Clinical chemistry parameters	Glucose & Insulin; Total cholesterol, LDL, HDL, triglycerides, uric acid, Glycated Serum Proteins & HbA1C.	At baseline (after run-in period of 2 weeks) and after 4 weeks intervention	No